Migraine Preventive Medications for Migraine

Recruiting at 4 trial locations

Overseen By Dani C Smith, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: CGRP-targeting, Beta-blockers, Opioids, Butalbital

Disqualifiers: Epilepsy, Severe hepatic impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

1335 Participants Needed

Trial Summary

What is the purpose of this trial?

This goal of this study is to compare three medications used for migraine preventive treatment. This study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others. Research participants will: * Be randomly assigned to one of the three medications. * Provide information about their migraine pattern using a daily headache diary and during research visits.

Research Team

Todd J Schwedt, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals who frequently experience migraines. Participants will be randomly assigned to one of three medications and must track their migraine patterns daily. Specific eligibility details are not provided, but typically participants should meet certain health criteria.

Inclusion Criteria

Not pregnant or breastfeeding

Women of childbearing potential must use effective contraception

Ability to provide informed consent

Exclusion Criteria

I cannot take atogepant, propranolol, or topiramate due to health reasons.

I am currently taking atogepant, propranolol, or topiramate.

I have taken atogepant, propranolol, or topiramate before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Randomization

Participants are randomized to one of the three medications after the initial screening period

1 week

1 visit (in-person)

Treatment

Participants receive the assigned study medication for 12 weeks

12 weeks

4 visits (in-person) at weeks 4, 8, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

2 visits (in-person) at weeks 24 and 48

Treatment Details

Interventions

• Atogepant
• Propranolol
• Topiramate

Trial Overview The study compares the effectiveness and tolerability of three migraine preventive medications: Atogepant (60 mg), Propranolol (160 mg), and Topiramate (100 mg). Patients will be placed into groups by chance to receive one medication.

Participant Groups

Group I: Topiramate Active Control 1 Intervention

Participants randomized to this arm will take up to 100 mg daily for 12 weeks .

Group II: Atogepant Active Control 1 Intervention

Participants who are randomized to this arm will take up to 60mg daily for 12 weeks.

Group III: Propranolol Active Control 1 Intervention

Participants randomized to this arm will take up to 160 mg daily for 12 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois